Study to Evaluate Multiple Doses of Fluconazole, a CYP3A4 and CYP2C9 Inhibitor, on the Pharmacokinetics of CTP-543 in Healthy Subjects

NCT05478772 | Completed Phase 1 FDA Drug

• 1 other identifier: CP543.1015
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

A single center, Phase 1, open-label, fixed-sequence, drug-drug interaction study to evaluate the effect of multiple doses of Fluconazole, a CYP3A4 and CYP2C9 inhibitor, on the pharmacokinetics (PK) of CTP-543 in healthy subjects

Conditions

Health Volunteers

Keywords

CTP-543

Outcome Measures

Primary Outcomes (6)

• Cmax

  Maximum observed concentration

  Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose

• Tmax

  Time to reach maximum observed concentration

  Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose

• λz

  Terminal elimination rate constant

  Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose

• t1/2

  Apparent terminal half-life

  Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose

• AUC0-tlast

  Area under the concentration-time curve from time 0 to the time of the last observed/measured non-zero concentration

  Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose

• AUC0-inf

  Area under the concentration-time curve from time 0 extrapolated to infinity

  Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose

Secondary Outcomes (1)

• Assessment of Safety and Tolerability following administration of CTP-543

  Continuous from screening (within 21 days prior to Day 1) through Discharge (approximately 7 days after last study drug administration)

Study Arms (1)

CTP-543 and Fluconazole Treatment

EXPERIMENTAL

On Day 1, each subject will receive a single oral dose of 12 mg CTP-543. Following a washout on Day 2, each subject will receive an oral dose of 200 mg fluconazole once daily on Days 3 through to Day 8. On Day 7, approximately 1 hour after the 200 mg dose of fluconazole, each subject will receive a single oral dose of 12 mg CTP-543.

Drug: CTP-543; Drug: Fluconazole

Interventions

CTP-543 DRUG

12 mg on Day 1 and Day 7

CTP-543 and Fluconazole Treatment

Fluconazole DRUG

200 mg once daily on Days 3 through to Day 8

CTP-543 and Fluconazole Treatment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy, adult, male or female, aged 18-60 inclusive
• Non-smoker who has not used nicotine-containing products for at least 3 months prior to the first dosing
• Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at screening
• If of reproductive age, willing and able to use a medically highly effective form of birth control 4 weeks prior to first dose, during the study and for 30 days following last dose of study medication.
• Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol

You may not qualify if:

• History or presence of clinically significant medical or psychiatric condition or disease
• History or presence of alcohol or drug abuse within the past 2 years
• History or presence of hypersensitivity or idiosyncratic reaction to the study drugs or related compounds
• Presence or history of significant gastrointestinal, liver or kidney disease, or any other condition that is known to interfere with drug absorption, distribution, metabolism or excretion, or known to potentiate or predispose to undesired effects
• History of prolonged QT syndrome or a QTc interval with Fridericia's correction (QTcF) \> 450 msec for males or QTcF \> 470 msec for females at Screening visit or prior to the first dosing
• Abnormal liver function at Screening
• Females who are nursing, pregnant, or planning to become pregnant while in the study, and for 30 days after last dose of study drug
• Positive results for coronavirus infection (COVID-19) at Screening or check-in
• Positive drug or alcohol results at Screening or check-in
• Positive results at Screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV)
• Vaccination with a live attenuated vaccine up to 6 weeks prior to dosing. Live vaccines include (but are not limited to) the measles, mumps, and rubella (MMR) vaccine; intranasal flu vaccine; and Zostavax for herpes zoster

Sponsors & Collaborators

• Concert Pharmaceuticals: lead

Study Sites (1)

Clinical Pharmacology of Miami, LLC

Miami, Florida, 33014, United States

Location

MeSH Terms

Interventions

Fluconazole

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: July 28, 2022
• Study Start: July 11, 2022
• Primary Completion: August 6, 2022
• Study Completion: August 12, 2022
• Last Updated: August 30, 2022

Record last verified: 2022-08

Locations

US (1)